NDC 65197-002

Dyrenium

Triamterene

Dyrenium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Wellspring Pharmaceutical Corporation. The primary component is Triamterene.

• Product ID: 65197-002_96d12576-d968-41bc-ad64-fd3812e09f25
• NDC: 65197-002
• Product Type: Human Prescription Drug
• Proprietary Name: Dyrenium
• Generic Name: Triamterene
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1999-10-01
• Marketing End Date: 2019-12-31
• Marketing Category: NDA / NDA
• Application Number: NDA013174
• Labeler Name: WellSpring Pharmaceutical Corporation
• Substance Name: TRIAMTERENE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]
• NDC Exclude Flag: N

Packaging

NDC 65197-002-06

6 CAPSULE in 1 BOTTLE (65197-002-06)

• Marketing Start Date: 1999-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65197-002-01 [65197000201]

Dyrenium CAPSULE

• Marketing Category: NDA
• Application Number: NDA013174
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-10-01
• Marketing End Date: 2019-12-31

NDC 65197-002-06 [65197000206]

Dyrenium CAPSULE

• Marketing Category: NDA
• Application Number: NDA013174
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-10-11
• Marketing End Date: 2019-12-31

Drug Details

Active Ingredients

Ingredient	Strength
TRIAMTERENE	50 mg/1

OpenFDA Data

• SPL SET ID: 5012f997-9fb2-4c3d-99fd-4f7efd7c39af
• Manufacturer:
  • WellSpring Pharmaceutical Corporation
• UNII:
  • WS821Z52LQ
• RxNorm Concept Unique ID - RxCUI:
  • 198312
  • 198313
  • 208675
  • 208674
• UPC Code:
  • 0365197002061
  • 0365197002016
  • 0365197003013

Pharmacological Class

• Decreased Renal K+ Excretion [PE]
• Increased Diuresis [PE]
• Potassium-sparing Diuretic [EPC]

NDC Crossover Matching brand name "Dyrenium" or generic name "Triamterene"

NDC	Brand Name	Generic Name
59212-002	Dyrenium	Triamterene
59212-003	Dyrenium	Triamterene
65197-002	Dyrenium	Triamterene
65197-003	Dyrenium	Triamterene
68151-1494	Dyrenium	Triamterene
66993-831	triamterene	Triamterene
66993-832	Triamterene	Triamterene